5 Tips To Minimizing Risk In Your Cold Chain PackagingSource: Infitrak
By Jean Bédard, President and CEO, Infitrak
As pharmaceuticals have become more and more regulated, companies have had the need to build or evaluate their cold chain processes and packaging to comply with those regulations and minimize risk. The challenge with those regulations is that although they may provide guidance, they may not be optimized for your region of the country, for the type of carriers you use, or the sustainability standards that are demanded by consumers and governments alike. So, how do you navigate through these issues while still keeping your eye on profits and patient safety? Below are 5 tips to ensuring your packaging and processes meet the needs of your company, your customers and your compliance standards:
1) Cold chain integrity. Where is your weakest link?
You can dot every “i” and cross every “t”, but unless you know where your gaps are, you are vulnerable. Medications get left in the sun, unexpected weather changes cause failures in equipment, temperatures can fluctuate from region to region. So how do you find that weak link and do you have the resources and time to resolve the issues? Document your risk priorities for every “touch point” in your process do determine precedence. Just like any situation, when overwhelmed, make a list. Shipping studies and gap analysis are key projects you should look at for determining where gaps may occur. It forces you to look at the number of times your product changes hands, allowing you to assess the critical shipment hand-off points and manage the risk presented at these points. Once you have done that you can establish a quality system and validation protocol with your employees and carriers. This will also allow you to create a repeatable and transferable process for success. On a regular basis you would then need to review this protocol, test security measures, and determine if a robust program is still in place to mitigate the risk.